Clinical trial · Interventional
Pictorial Support in Person-centred Care for Children (PicPecc)
A Person-centred Approach to Pictorial Support in Care for Children (PicPecc)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
Introduction: Person-centred care is based on the assumption that every person has resources that should be used in the care situation. In order for this to happen the patient has to be able to effectively communicate his/her symptoms. This protocol describes the analysis of a digital picture-based tool for communication support for children with cancer aged 5-17 years, who undergo high-dose methotrexate treatment. The advantage of a non-linguistic based platform, beside the expected clinical outcomes, is that it can be used in multiple national studies with minimal translation. Methods and analysis: Two studies will be conducted in a hybrid design, i.e., a crossover design will be used for the intervention (effects), and a mixed-methods design will be used for the process evaluation. Qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals as part of the process evaluation. The interviews will address the experiences of the intervention and frequency of use from the child's perspective. Interview transcripts will be analyzed qualitative descriptively. The digital communication tool will collect child self-reports of symptoms/emotions. The children will be monitored for biomarkers of stress and pain (neuropeptides, neurosteroids and peripheral steroids) in venous blood samples, in-app estimation levels for the children, drug consumption. Person-centeredness will be evaluated with the questionnaire Visual CARE Measure. Ethics: Ethical approval was obtained from the Swedish Ethical Review Authority (ref 2019-02392; 2020-02601).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Communication | — | UNRESOLVED | — |
| Symptoms and Signs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pictorial support in person-centred care for children (PicPecc) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- The child will firstly undergo phase A without the digital reporting and communication tool. The child will secondly undergo phase B with the digital reporting and communication tool (i.e., A, B).
- interventionNames
- Device: Pictorial support in person-centred care for children (PicPecc)
- type
- EXPERIMENTAL
- label
- Group 2
- description
- The child will firstly undergo phase B with the digital reporting and communication tool. The child will secondly undergo phase A without the digital reporting and communication tool (i.e., B, A).
- interventionNames
- Device: Pictorial support in person-centred care for children (PicPecc)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Children with cancer, 5-17 years * The children´s legal guardians * Healthcare professionals who take care of these children * The child needs to have a cognitive level of approximately five years (i.e., be able to understand a numeric rating scale (NRS)). Exclusion Criteria: \- Children 0-4 years
References
Publications (6)
- BACKGROUNDNilsson S, Bjorkman B, Almqvist AL, Almqvist L, Bjork-Willen P, Donohue D, Enskar K, Granlund M, Huus K, Hvit S. Children's voices--Differentiating a child perspective from a child's perspective. Dev Neurorehabil. 2015 Jun;18(3):162-8. doi: 10.3109/17518423.2013.801529. Epub 2013 Aug 7. PMID 23924164
- BACKGROUNDLin B, Gutman T, Hanson CS, Ju A, Manera K, Butow P, Cohn RJ, Dalla-Pozza L, Greenzang KA, Mack J, Wakefield CE, Craig JC, Tong A. Communication during childhood cancer: Systematic review of patient perspectives. Cancer. 2020 Feb 15;126(4):701-716. doi: 10.1002/cncr.32637. Epub 2019 Dec 10. PMID 31821552
- BACKGROUNDCurran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. PMID 22310560
- BACKGROUNDO'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954. PMID 31420394
- BACKGROUNDNilsson S, Holstensson J, Johansson C, Thunberg G. Children's Perceptions of Pictures Intended to Measure Anxiety During Hospitalization. J Pediatr Nurs. 2019 Jan-Feb;44:63-73. doi: 10.1016/j.pedn.2018.10.015. Epub 2018 Nov 3. PMID 30683283
- DERIVEDNilsson S, Wiljen A, Bergquist J, Chaplin J, Johnson E, Karlsson K, Lindroth T, Schwarz A, Stenmarker M, Thunberg G, Esplana L, Frid E, Haglind M, Hook A, Wille J, Ohlen J. Evaluating pictorial support in person-centred care for children (PicPecc): a protocol for a crossover design study. BMJ Open. 2021 May 4;11(5):e042726. doi: 10.1136/bmjopen-2020-042726. PMID 33947726